Clearance of 25-hydroxyvitamin D3 During Vitamin D3 Supplementation
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/5/2018 |
| Start Date: | June 1, 2018 |
| End Date: | December 2020 |
The goal of this study is to determine how 25(OH)D3 clearance is affected by vitamin D3
supplementation using a gold standard pharmacokinetic approach. We expect that this study
will enhance interpretation of available diagnostic tests, inform the results of ongoing
large clinical trials of vitamin D supplements, and help develop new strategies to target
vitamin D to improve health.
supplementation using a gold standard pharmacokinetic approach. We expect that this study
will enhance interpretation of available diagnostic tests, inform the results of ongoing
large clinical trials of vitamin D supplements, and help develop new strategies to target
vitamin D to improve health.
Inclusion Criteria:
- Successful prior completion of related protocol CLEAR (NCT02937350) or CLEAR-CF
(NCT03104855)
- Age ≥ 18 years
- Self-reported race Caucasian, African American, or African
Exclusion Criteria:
- Primary hyperparathyroidism
- Gastric bypass
- Tuberculosis or sarcoidosis
- Current pregnancy
- Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic
encephalopathy, bilirubin >=2 mg/dL, serum albumin <=3.5 g/dL, or PT >= 4 seconds)
- History of kidney transplantation (unless failed transplant now treated with
hemodialysis)
- Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce
CYP24A1 within 4 weeks (wash-out allowed)
- Serum calcium > 10.1 mg/dL
- Hemoglobin < 10 g/dL
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